Strategies for Promoting the Scientific Integrity of Nursing Research in Clinical Settings

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JNSD Journal for Nurses in Staff Development & Volume 26, Number 5, 200Y205 & Copyright B 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins

Roseann Barrett, PhD, RN

Magnet hospitals were surveyed to determine the processes designation is given to healthcare organizations that em- used to promote the integrity of nursing research conducted in body nursing excellence. Hospitals that have achieved clinical settings. Results indicated that four central processes, Magnet designation must be able to demonstrate the pres- institutional review board review, nursing research council ence of well-established and operationalized structures review, nursing research mentorship, and reliance on and processes for research and evidence-based prac- personal and professional values, were used to educate, tice (American Nurses Credentialing Center, 2007a). It monitor, and oversee the integrity of research conducted by is hoped that, by understanding the processes currently bedside nurse scientists. Staff development educators are being used by these institutions, strategies may be identi- challenged to provide instruction regarding the process of fied that may contribute to the development of a proactive nursing research and all elements of scientific integrity. and consistent framework by which to ensure the scien- Research is needed to test the effectiveness of the processes tific integrity of the nursing research conducted in clinical identified in this investigation in promoting the quality and settings. The research question that was answered by this integrity of nursing research conducted in clinical settings. investigation is, “How is scientific integrity in nursing research promoted in Magnet hospitals?”

esearch is an essential component in profes- REVIEW OF THE LITERATURE sional nursing practice. Ketefian (2001) suggested Lenz and Ketefian (1995) suggested that “externally im- R that the pace and growth of nursing research has posed rules and regulations, rather than internalized been faster than that of the understanding of ethical issues ethics, integrity and informal norms regarding personal and social considerations that are of paramount importance and professional responsibility seem to take precedence in the conduct of science. Understanding scientific integrity as the arbiters of science” (p. 213). Guidelines for the ethi- and the factors that influence researchers to adhere to ethical cal conduct of research involving human subjects have standards is critical to the protection of human subjects in been developed by various federal and private agencies. nursing research and to the advancement of nursing science Research involving human subjects must undergo an ethi- (Jeffers, 2005). The conduct of nursing research is no longer cal review by an institutional review board (IRB) to ensure , limited to academic settings; the most useful patient care re- that the participants rights as research participants are search is also conducted in clinical settings by bedside protected, just one aspect of promoting scientific integrity nurse scientists (Houser & Bokovoy, 2006). Although (Hueston et al., 2006). IRB review also involves assuring nursing research efforts in clinical settings have increased, compliance with federal regulations such as the Code there is little evidence of a consistent infrastructure to pro- of Federal Regulations, Title 45 and 21 (Department of mote an environment of nursing research integrity (Jeffers, Health and Human Services [DHHS], 2005). 2005; Newhouse & Mills, 2001). Two reports released by the Institute of Medicine The purpose of this investigation was to describe the (2002, 2003) focused on research integrity and the effec- current processes that are used in Magnet hospitals to pro- tiveness of IRBs. The reports proposed the importance mote the scientific integrity of nursing research. Magnet of the role of the research environment in promoting research integrity and recommended that institutions Roseann Barrett, PhD, RN, is Director of Nursing Research, Patient develop proactive organizational frameworks for the re- Care Services, St. Joseph Hospital, Nashua, New Hampshire. sponsible conduct of research. ADDRESS FOR CORRESPONDENCE: Roseann Barrett, 46 Fox Run, Guidelines for promoting scientific integrity involve Groton, MA 01450 (e-mail: [email protected]). many elements and may vary by setting or discipline. The author has disclosed that she has no significant relationships with, or financial interest in, any commercial companies pertaining to this educa- Discipline-specific guidelines for promoting the scientific tional activity. integrity of nursing research have been developed by the DOI: 10.1097/NND.0b013e31819b55dd Midwest Nursing Research Society (2002). The guidelines

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Copyright @ 2010 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. were developed to “promote the integrity of nursing science for institutional- and professional-level approaches to by integrating principles of science and ethics, and to en- promote scientific integrity. Responses from 38 schools hance the sense of social responsibility of scientists” (P.V.). indicated that, although information about misconduct The domains of nursing scientific integrity identified in the and scientific integrity was included in required research guidelines encompass several areas, including conflict of methods courses and optional workshops, the extent , interest, data stewardship and access, data management, and scope of instruction was variable. This study s find- collaboration, and publication practices, in addition to the ings indicated that a high value was placed on informal protection of the rights of human subjects in research. studentYmentor relationships as a means to socialize stu- A challenge faced by some bedside nurses conducting dents to the role of researcher. In addition, if they ex- research in clinical settings may be a rusty and unused re- isted, institutional guidelines for research integrity were search skill set (Houser & Bokovoy, 2006). To improve found to be more specific than were federal guidelines patient care by facilitating the conduct of evidence-based and focused primarily on handling misconduct rather practice and nursing research, some hospitals have estab- than promoting responsible science. The authors suggest lished nursing research centers or councils and employed the need for a more proactive and consistent approach nursing research consultants. The focus of these councils is to promoting scientific integrity. to provide structure, education, and mentorship about evi- The development of nursing knowledge through the dence-based practice and research fundamentals including conduct of research is essential to providing quality pa- terminology, research methods, and the research process tient care. Research practices may be influenced by in- (Hudson-Barr & King, 2004; Newhouse & Mills, 2001). ternal norms and external guidelines and may vary by The membership of nursing research councils may include institution, discipline, and research setting. After a review nurses with an interest in nursing research and who may of the literature, it may be suggested that there are cur- have varied educational preparation and research exper- rently no consistent or comprehensive processes for pro- tise. Most nurses in clinical practice may not have received moting the scientific integrity of nursing research information about scientific integrity or the role and re- conducted in clinical settings in place. sponsibilities of a nurse researcher during their education programs (Broome, 2003). Little is known about the ways METHODS in which bedside nurse scientists learn about scientific integrity, the content of the information they receive, or the Research Design formal guidelines and informal norms that guide the con- A descriptive/exploratory design was used to describe duct of their investigations and related activities. the processes and strategies used in Magnet hospitals Jeffers (2005) proposed an internal control model for to promote the scientific integrity of nursing research. promoting an environment of research integrity. The model shifts attention from the behavior of the individual Sample researcher to examination of organizational control Because the study examined the processes and frame- processes within the research environment including in- works for promoting scientific integrity within clinical formation and communication, monitoring, control settings, the Magnet hospital rather than the individual activities, risk assessment, and control environment. The completing the survey was the unit of analysis. At the time author suggested that the model may be used as a frame- the study was conducted, there were 260 Magnet hospi- work to assess and evaluate research integrity at the tals in the United States and Australia (American Nurses organizational level to provide a “snapshot” of the quality Credentialing Center, 2007b). A representative from each and scientific integrity of the current nursing research envi- Magnet hospital was identified from a list of attendees at ronment. Testing the utility of the model in an academic the 2007 Magnet conference. Potential participants were setting is currently taking place (B. Jeffers, personal com- asked to forward the survey to the appropriate individual munication, February 16, 2007). if he or she was not the person responsible for the over- There are many non-empirically based recommenda- sight of nursing research at the hospital. tions regarding practices that best promote scientific integrity in nursing research (Jeffers, 2005; Ketefian, Human Subjects, Protection 2001; Macrina & Munro, 1995; Midwest Nursing Research After IRB approval, a letter of introduction was sent to Society. 2002), but the body of empirical knowledge a representative from each Magnet hospital explaining about promoting the scientific integrity of nursing re- the purpose of the study, the voluntary nature of partici- search is scarce and focused on the academic setting. pation, and that all information obtained in the study Schools of nursing with doctoral programs were sur- would be kept strictly confidential. Consent to partici- veyed by Lenz and Ketefian (1995) to determine strate- pate in the investigation was given by returning the gies for promoting research integrity and suggestions completed study survey back to the investigator.

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Copyright @ 2010 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. Measurement searcher. Nursing research experts were also employed Survey questions about the following items were used to on either a part-time (15%), per-diem (2%), or consulting describe the processes in place for the administration of basis (9%). Eleven percent of the hospitals reported nursing research at participating Magnet hospitals: name more than one nursing research expert on the staff (most and title of person completing the survey, name and title were less than one full-time equivalent), and 9% were of the individual responsible for the oversight of nursing hoping to either establish or fill an open nursing research research activities, presence of on-site nursing research ex- position in the future. The person identified as being re- pert and the qualifications and employment status of the sponsible for the oversight of nursing research varied. expert, and whether the hospital had a university or medi- The most commonly identified individual was a doctorally cal school research affiliation. prepared (65%) nursing director with other responsibili- For this investigation, research integrity was defined as ties, in addition to the oversight of nursing research. adherence to rules, regulations, guidelines, and commonly Affiliations with local colleges, universities, or medical accepted professional codes or norms (DHHS Office of schools were a common (66%) means of obtaining expert Research Integrity, 2001). A modified version of the 21-item assistance with nursing research programs. questionnaire of Lenz and Ketefian (1995) that described strategies for promoting nursing research integrity in doc- Definition of Research Integrity toral programs was used to collect data. Items in the Most of the participants (77%) stated that the hospital had questionnaire dealt with education approaches, sociali- a clearly articulated nursing research mission statement. A , zation mechanisms, use of guidelines, rules and regula- majority (59%) reported that the hospital s definition of re- tions, the role of various institutional agents as oversight search integrity was the same as that of the DHHS Office bodies, the protection of human subjects, publication of Research Integrity (2001), “adherence to rules, regula- practices, and methods for data stewardship and access. tions, guidelines, and commonly accepted professional Face validity of the questionnaire was determined after re- codes or norms.” Surprisingly, 29 participants (41%) review by two doctorally prepared expert nurse researchers ported that they had no official definition of research , and two master s prepared nurse researchers. integrity or left the question unanswered.

Procedure Process Used to Promote the Integrity of A mixed method was used to recruit participants for the Nursing Research study. The literature suggests that combining online and Almost all (97%) of the hospitals used several processes to offline contact strategies may be an effective way to im- promote the responsible conduct of nursing research. Re- prove response rates to surveys (Yun & Trumbo, 2000). view by the IRB (97%) was the most frequently reported Representatives of the Magnet hospitals were first con- process followed by formal mandatory protection of hu- tacted by mail and received a packet that included a man subjects training (70%). Table 1 summarizes the letter that explained the purpose of the study and in- structions for completing and returning the enclosed survey.After1month,thesurveyandaninvitationto TABLE 1 Processes Used to Promote participate in the investigation were also posted on a list- Responsible Nursing Research serv for Magnet hospital nursing research. Process % n DATA ANALYSIS Review of proposals by the institutional 97 69 review board Completed surveys returned to the investigator were examined for eligibility and completeness before being included Formal mandatory education about the 69 49 in the study database. Seventy-one (34%) completed sur- protection of human subjects veys were included in the final data analysis. Data were Review of proposals by the nursing 69 49 entered into SPSS, Version 12, for Windows and summarized research council with descriptive statistics. Responses to open-ended questions and comments written on the surveys by participants Review of the proposal by the nurse researcher 63 45 were analyzed with content analysis to identify themes and Informal education abut the responsible 51 36 to categorize processes that were not included in the survey. conduct of nursing research and/or the protection of human subjects RESULTS Formal mandatory education about the 28 20 Administration of Nursing Research responsible conduct of nursing research A majority (58%) of the Magnet hospitals in this sample Review of the proposal by the ethics committee 6 4 reported having a full-time equivalent for a nurse re-

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Copyright @ 2010 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. processes used by the hospitals in this sample to promote TABLE 2 Types of Projects Reviewed by the responsible conduct of nursing research. Nursing Research Councils Institutional review boards were also the most frequently reported source of guidelines, norms, and stan- Projects % n dards (94%) and processes for protecting the rights of Research proposals developed by staff nurses 77 50 human subjects (97%) and for identifying potential or actual risks to nursing research integrity (99%). Evidence-based practice projects 64 42 Nursing research councils and review by nursing re- Research proposals developed by external 55 36 search mentors were important processes in promoting nurse researchers the responsible conduct of nursing research. Nursing research councils provided peer review of nursing re- Quality improvement projects 26 17 search and evidence-based practice projects at 92% of Research proposals developed by hospital staff 19 12 the hospitals; expert advice from nursing research mentors (99%) and nursing research consultants (61%) were also used. Elements of Research Integrity Issues of authorship and publication were most often ad- Resources for New Nurse Researchers dressed informally among the research team (59%) and Nurses new to research had a variety of resources avail- by advice from a nurse researcher (56%). Forty-two per- able to them. Almost all of the sample (93%) provided cent of the sample reported that there was no formal multiple types of formal and informal instruction about process in place to address plagiarism and ensure the the conduct of nursing research. The most commonly re- appropriate citation of the work of other researchers. ported experiences provided to nurses new to research Guidance about data management and storage most of- were research mentorship (76%) and advice from a nurs- ten came from IRB recommendations (61%), data safety ing research consultant (80%). Workshops (69%), formal and monitoring boards (13%), and nursing research education sessions (49%), and Web-based instruction council policies (11%). Twenty-five percent of the hospi- (46%) about the conduct of nursing research were also tals reported that data management and storage were left available. Education about the protection of human sub- to the discretion of the individual researcher, and 30% jects (90%) and research methods (67%) was offered at a indicated that there were no formal processes in place majority of the hospitals. Instruction regarding elements of to guide nurse researchers about data management scientific integrity other than the protection of human sub- issues. Strategies to ensure that data were reported accu- jects such as data stewardship and access (35%), data rately varied among institutions. Review by a nurse re- management (48%), and authorship (48%) was provided searcher (53%) was the principal means of ensuring by less than half of the participating hospitals. the accuracy of data from nursing research studies. Thirty-seven percent of the hospitals surveyed had no Nursing Research Oversight mechanism currently in place to ensure that data were Almost all of the hospitals (99%) in this sample reported reported accurately. that nursing research mentors were available to work with Review by the nursing research council (24%) and a , nurses. The mentors were predominantly master sanddoc- nurse researcher (36%) were the most commonly re- torally prepared nurses (87%) already employed by the ported strategies used to prevent plagiarism; 41% of hospital or nursing research consultants (62%). Ninety- the hospitals surveyed reported that they had no formal two percent of the sample reported that there was a nursing process in place to ensure the appropriate citation of the research council at the institution that met on a monthly work of other researchers. Actual or potential conflicts of (83%) basis. Projects reviewed by the nursing research interest were most often identified through review by councils varied and are summarized in Table 2. several entities including the IRB (73%), the nursing re- More than half of the sample (59%) reported that the search council (41%), and review by a nurse researcher ongoing oversight of nursing research was a shared re- (42%). Nearly half (42%) of the participants relied on the , sponsibility within the organization. The IRB (56%), a researchers personal and professional values, reporting nurse researcher (58%), and the nursing research council that it was the responsibility of the principal investigator (55%) were most commonly identified as being respon- to disclose any conflict of interest. Cases in which the sible for overseeing the integrity of nursing research. The integrity of nursing research was inadequate or compro- most frequent pattern of nursing research oversight was mised were most often handled by IRB review and one in which nurse researchers and nursing research action (79%), review by a nurse researcher (42%), or re- councils performed an initial review of the nursing review by the nursing research council (38%). Half of the search project before IRB review. hospitals in this sample indicated that review and action

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Copyright @ 2010 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. by the IRB, the nursing research council, and a nurse researcher would all occur in these situations.

The Sample,s Opinion Half of the participants responded to the open-ended question, “What strategies do you think should be used to promote the integrity of nursing research in clinical settings?” Responses indicated that IRB and organizational oversight and regular reports to committees and department heads were considered necessary components of promoting the integrity of nursing research. Basic and continuing education about the responsible conduct of research was also cited as being essential. Formal education programs that addressed the research process, elements of research integrity, and the protection of human subjects were recommended. The role of research mentors as role models was seen as a valuable and effec- FIGURE 1 Processes used to promote the integrity of nursing research tive strategy for ensuring the integrity of nursing research. in clinical settings. IRB = institutional review board. One participant described the importance of research , mentors ongoing support and guidance, regarding integrity and professional responsibility. Sev- Nurses doing clinical research (especially those new to eral participants reported that guidance about elements it) need to be educated and supported. They need to of research integrity such as conflicts of interest, author- be given a clear understanding of why integrity matters ship, plagiarism, and data management was usually left and then supported through the tiresome part of the up to the discretion of the individual investigator, assuming process (when one is likely to think of taking shortcuts). that the investigator had knowledge and understanding of The success of having completed a study which they the role these issues play in promoting research integrity. know has integrity will most likely be the best way to The second process involves the role of the nursing re- assure integrity of future research. search mentor. Lenz and Ketefian (1995) described the , Several participants noted that, although nursing re- research mentor s role in providing informal instruction search councils provided structure for the process of and ongoing guidance as being critical for socializing nursing research, there was still a need for clear guide- nursing students as researchers. Guidelines for scien- lines concerning research integrity and issues such as tific integrity prepared by the Midwest Nursing Research authorship, conflicts of interest, funding, quality improve- Society (2002) clearly explain the role of the research ment versus research, and accountability. mentor, “Senior scientists instruct less experienced col- leagues formally and informally through example, dis- LIMITATIONS cussion, and collaboration. Appropriate supervision is This study was limited by the use of an investigator- provided to nurture and instruct young scientists to foster developed questionnaire that has not been tested for re- sound research practices” (p. 14). liability and validity. In addition, because the sample Successful research mentoring relationships result in no- included only hospitals that have been awarded Magnet des- vice researchers with a strong sense of integrity and ignation, generalizability to other clinical settings may confidence in their research skills (Wocial, 1995). The par- be limited. ticipants in this study indicated that the leadership, monitoring, and role-modeling activities of nursing research CONCLUSIONS mentors contributed positively to the development of bed- The results of this investigation indicate that the Magnet side nurse scientists and the integrity of their research. hospitals surveyed used four central processes to promote Nursing research councils are the third level in the the scientific integrity of nursing research: IRB oversight, framework and provide structure to the process of pro- peer review, research mentorship, and personal and promoting the scientific integrity of nursing research in the fessional values. Figure 1 illustrates the processes as a pro- form of peer review of research, oversight of projects, posed framework for promoting nursing research integrity and education about the research process and elements , in clinical settings. of scientific integrity. As a part of nursing s shared gover- In most cases, the processes were implemented in a nance structure, nursing research councils empower hierarchal succession building on a foundation of the re- nursing staff to participate in the decision-making process , searchers internalized personal and professional values related to nursing research and evidence-based practice

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Copyright @ 2010 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. and therefore contribute to an environment that promotes References research integrity. American Nurses Credentialing Center. (2007a). Frequently asked Finally, reliance on the guidelines, rules, regulations, questions about research/evidence-based practice. Retrieved , February 22, 2007, from http://www.nursecredentialing.org/ and review by the organization s IRB was the last process ancc/magnet/getall.cfm in the framework and the most frequently reported pro- American Nurses Credentialing Center. (2007b). List of all Magnet- cess for ensuring the integrity of nursing research. A par- designated facilities. Retrieved April 5, 2007, from http:// ticipant commented that review of nursing research www.nursecredentialing.org/ancc/magnet/getall.cfm Broome, M. (2003). Scientific integrityVthe cornerstone of knowledge. proposals by a “duly constituted IRB” was necessary be- Journal of Neuroscience Nursing, 35(1), 56Y59. cause “to accept that hospital/practice setting research is Department of Health and Human Services. (2005). 45 CFR. different from academic research related to standards is Retrieved February 15, 2007, from http://ohsr.od.nih.gov/ not acceptable. Scientific merit is.” guidelines/45cfr46.html Department of Health and Human Services Office of Research Integrity. (2001). Federal policy on research misconduct. IMPLICATIONS Retrieved February 15, 2007, from http://ori.dhhs.gov The development of nursing knowledge through the con- Houser, J., & Bokovoy, J. (2006). Clinical research in practice. Sudbury, MA: Jones & Bartlett. duct of research is essential to providing quality patient Hudson-Barr, D., & King, C. (2004). From nursing research committee care. Research integrity is a complex concept that may be to nursing research council. 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Journal of Nursing Administration, 31(12), 583Y587. Sheehan, J. (1993). Issues in the supervision of post-graduate signed to identify and develop nursing research mentors research students in nursing. Journal of Advanced Nursing, are also needed. The skills needed to do research are differ- 18, 880Y885. ent from those needed to supervise young researchers Wocial, L. (1995). The role of mentors in promoting integrity and (Sheehan, 1993). Research mentor training should prepare preventing scientific misconduct in nursing research. Journal of Y new research mentors not only to guide nurses through Professional Nursing, 11(5), 276 280. Yun, G., & Trumbo, C. (2000). Comparative responses to a survey the responsible conduct of research but also to cultivate per- executed by post, e-mail & Web form. Journal of Computer sonal and professional values, accountability, and trust. Mediated Communication, 6(1).

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